PROCEDURE AND MACHINE FOR ELECTRO-INDUCING/STIMULATING DEEP-LAYERED MUSCLE CONTRACTIONS USING A BIPHASIC FARADIC PULSE SEQUENCE
Document Type and Number:
WIPO Patent Application WO/2003/090845
Kind Code: A2
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Abstract:
A procedure and machine promotes healing by causing muscle fasciculation and contraction relaxation cycles that effectively pump blood through the microcirculation, draining the venous beds and raising the tissue oxygen levels. A high phase charged system, a power source (34), timer (31) and pulse generator (32) is electronically pulsed and adjusting to induce deep-layered muscle contractions, causing greatly increased flow rates of both blood and lymphatics, patency of vessels permitting, and forcing blood into the microcirculation of the treated tissue. The machine electrical waveform stimulates angiogenesis, facilating new tissue growth and repair in the healing process and raises the metabolic rate in the treated tissues.
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Inventors: Buchner, Kelly Wayne (3171-A S. 129th E. Ave, Tulsa, OK, 74134, US)
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Application Number: PCT/US2003/012685
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Publication Date: November 06, 2003
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Filing Date: April 24, 2003
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Assignee: MICROVAS TECHNOLOGIES, INC. (6130 S. Memorial, Tulsa, OK, 74133, US)
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International Classes: A61N1/00; A61N1/04; A61N1/18; A61N1/36
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Attorney, Agent or Firm: Catalano, Frank J. (Gable & Gotwals, 1100 Oneok Plaza 100 West 5th Stree, Tulsa OK, 74103-4217, US)
Claims:
AMENDED CLAIMS [received by the International Bureau on 22 January 2004 (22.0
| 1. | 04); original claim 1 canceled, original claims 25 replaced by new claims 25, claims 611 added (2 pages)] (Claim 1 canceled). |
| 2. | A procedure for therapeutic treatment of human and animal tissues comprising the steps of : identifying the tissue to be treated; sandwiching the identified tissue between one or more pairs of opposed emitter pads in contact with the skin; and applying a pulse sequence to the pairs of emitter pads to stimulate deep layered muscle contractions in the identified tissues, said pulse sequence being a biphasic rectangular pulse sequence having a waveform with nominal parameters including a duty cycle of approximately a 1. 5 seconds on and 1.5 seconds off. |
| 3. | A procedure according to claim 2, said nominal parameters further including a repetition frequency of approximately 57 Hz. |
| 4. | A procedure according to claim 2, said nominal parameters further including a pulse width of approximately 110 microseconds. |
| 5. | A procedure according to claim 2 further comprising the steps of : setting the intensity of the pulse sequence at an initial level; and incrementally increasing the intensity in response to the tolerance level of the patient. |
| 6. | A procedure according to claim 2, said nominal parameters further including a pulse period of approximately 18 miliseconds. |
| 7. | A procedure according to claim 6, said nominal parameters further including a time between initiation of positive and negative pulses of approximately 9 miliseconds. |
| 8. | A procedure according to claim 2, said nominal parameters including a peak open circuit voltage of approximately 140 volts with an output impedance of approximately 500 ohms. |
| 9. | A procedure for therapeutic treatment of human and animal tissues comprising the steps of : identifying the tissue to be treated; sandwiching the identified tissue between one or more pairs of opposed emitter pads in contact with the skin; and applying a pulse sequence to the pairs of emitter pads to stimulate deep layered muscle contractions in the identified tissues, said pulse sequence being a biphasic rectangular pulse sequence having a waveform with nominal parameters including a duty cycle of approximately a 1.5 seconds on and 1.5 seconds off, a repetition frequency of approximately 57 Hz, and a pulse width of approximately 110 microseconds. |
| 10. | A procedure according to claim 9, said nominal parameters further including a time between initiation of positive and negative pulses of 9 miliseconds. |
| 11. | A procedure according to claim 10, said nominal parameters including a peak open circuit voltage of approximately 140 volts with an output impedance of approximately 500 ohms. STATEMENT UNDER ARTICLE 19 (1) This statement specifically refers to the Amendment of Claims Under Article 19 filed on even date herewith for International Application Number PCT/US03/12685 entitled PROCEDURE AND MACHINE FOR ELECTROINDUCING/STIMULATING DEEP LAYERED MUSCLE CONTRACTIONS USING A BIPHASIC FARADIC PULSE SEQUENCE. Applicant submits this Amendment of Claims to further define patentable aspects of the invention. The claim amendments are within the scope of the invention disclosure, and the amendments are expected to have no impact on the description or drawings. This Amendment also conforms the claims to the claims as allowed in the priority application. . |
Description:
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PROCEDURE AND MACHINE FOR ELECTRO-INDUCING/STIMULATING DEEP-LAYERED MUSCLE CONTRACTIONS USING A BIPHASIC FARADIC PULSE SEQUENCE BACKGROUND OF THE INVENTION : This invention generally relates to therapeutic treatment of human and animal tissues and more particularly concerns a procedure and machine for electro-inducing or stimulating deep layered muscle contractions in tissues for the purpose of healing and treating wounds and various vascular deficiency ailments such as peripheral vascular disease, ischemic rest pain, diabetic neuropathy, pressure ulcers, slow or non-healing wounds, chronic low back pain, osteoarthritis, occupational problems such as carpal-tunnel syndrome, tendonitis and other sports injuries.
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An underlying characteristic of the above conditions and diseases is impaired circulation in-the capillary beds as well as nerve damage. Without blood flow to the tissues, oxygen and nutrients cannot get into the tissues and the waste products of metabolism cannot get out. This puts a severe stress on the tissues causing them to go into a survival mode. The cells use what limited resources they have to stay alive and higher functions, including healing and repair, as well as tissue mediated immunity, become essentially shut down. In most patients with severe disease, measured tissue oxygen levels have been found to be less than 15% of normal. Diabetics with impaired basement membrane function, Reynauds phenomena, Claudication states and other similar conditions all may have similar features due to this underlying characteristic.
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Essentially, every tissue in the body has intrinsic electrical properties.
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Because of this, it has been found that they respond to electrical stimulation.
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There have been many machines designed over the years to use electricity to affect the body in various ways to enhance the healing process. There are many variables in the use of electricity, including polarity, voltage, amperage,frequency and waveform. Although there are a variety of alternate technologies available today, the electronic parameters of known machines have limited applications.
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Hyperbaric oxygen therapy has been shown to be effective in healing ischemic ulcers. 100% oxygen at 2 atmospheres will give a partial pressure of oxygen 10 times normal. This greatly increases the rate of diffusion through the open face of the ulcer. Skin, however, is not as permeable to oxygen diffusion and oxygen delivery depends upon intact circulation as well. Hyperbaric oxygen therapy is a passive process and does not alter the underlying disease in the microcirculation.
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There are several procedures in practice using moist heat with occlusion dressings, infrared lamps, membranes with electrical currents and warm water whirlpool treatments. These have all shown some merit and have been effective in varying degrees. They all work by stimulating the arterioles in the capillary beds to dilate in response to infrared energy. These also are passive procedures, however, and do not alter the underlying disease in the microcirculation.
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Machines using high frequency interferential electrical currents are also effective. They stimulate the nerves in the skin and cause dilation of the capillary beds through the reflex pathways. However, this form of electrical current tends to be more superficial in the tissues and, therefore, less decisive and rapid in its healing effects.
.
Another procedure being used today consists of a garment placed around the diseased limb. Intermittent compression is then administered via compressed air from the attached machine. This again has proven to be effective to promote circulation and healing. by pumping the blood through the capillary beds. Pressure gradients are increased in the capillary beds but there is not necessarily the dilation of the arterioles as the other methods promote.
.
This procedure does not remodel the microcirculation either.
.
It is, therefore, an object of this invention to provide an electrical tissue treating procedure and machine which increases circulation in capillary beds.
.
Another object of this invention is to provide an electrical tissue treating procedure and machine which significantly remodels microcirculation so as to provide more permanent therapeutic improvement. A further object of this invention is to provide an electrical tissue treating procedure and machine which not only dilates arterioles but also, increases pressure gradients across the capillary beds to improve flow and oxygen levels and promote angiogenesis.
.
Yet another object of this invention is to provide an electrical tissue treating procedure and machine which provides deep layered muscle contractions and perfuses tissues with blood so as to afford more decisive and rapid healing than known methods and machines. It is also an object of this invention to provide an electrical tissue treating procedure and machine which facilitates more rapid and decisive healing of vascular deficiency ailments than known procedures and machines.
.
SUMMARY OF THE INVENTION : In accordance with the invention, a procedure and machine are provided to promote healing by causing muscle fasciculation and contraction relaxation cycles that effectively pump blood through the microcirculation, draining the venous beds and raising the tissue oxygen levels. This, in turn, supplies the oxygen and substrates necessary to greatly accelerate the healing process.
.
Pressure gradients are actually increased across the capillary beds with perfusion of blood into the designated area of the patient, in contrast to merely dilating the capillary beds. Therefore, the treatment has a potent effect on the microcirculation, which results in dramatic responses to treatment.
.
Transcutaneous oxygen monitors have demonstrated marked increases in tissue oxygen levels within minutes of initiating treatment. Tissue oxygen levels with successive treatments continue to improve.
.
A high phase charged system is electronically pulsed and adjusted to induce deep-layered muscle contractions, causing greatly increased flow rates of both blood and lymphatics, patency of vessels permitting, and forcing blood into the microcirculation of the treated tissue.
.
The machine electrical waveform stimulates angiogenesis, that is, budding of new capillaries and generation of denser capillary networks in the tissues. This lays the groundwork for new tissue growth and repair in the healing process. The machine electrical waveform also raises the metabolic rate in the treated tissues, which, it is theorized, helps the intimal lining of the arteries to metabolize the excess unused nutrients clogging them. Whatever the actual cause, the effect is improved blood flow that has been shown to be permanent, particularly in patients with neuropathy.
.
The procedure and machine have been tested on diabetics with severe ischemic ulcers in feet that were destined for amputation. This condition is usually associated with underlying osteomeyelitis, which does not respond well to standard therapy including systemic antibiotics and wound care. The present treatment greatly improves the management of this condition because theenhanced blood flow brings enhanced levels of antibiotics and healing to the affected area. In almost every case, the feet have been salvaged.
.
In addition, the machine's electrical waveform directly stimulates the activity of fibroblasts in the healing process. In the healing of ischemic ulcers the fibroblasts act first to build the framework upon which further cell types including skin and capillaries grow. The electrical current is a deep penetrating current that affects all tissues from the skin to the bone. Technically, the machine generates an [electrical] field between the emitter pads, in contrast to the electrical waveform of some machines that stay rather superficial in the tissues affecting primarily the top several millimeters. The system stimulates activity in bone cells as well, which accelerates fracture healing.
.
Finally, the procedure and machine have achieved excellent test case success in reversing neuropathy in the feet and legs of diabetics being treated.
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In follow up on this condition thus far, improvement has persisted for extended periods of time. There is no other known technology or treatment modality that has reversed diabetic neuropathy. The reason for this unique therapeutic benefit is not known. It may be due to improvement in the circulation that nourishs the nerves or due to an unknown direct action on the nerves themselves.
.
The procedure and machine have shown remarkable efficacy in dealing with the above difficult disease states. In comparison with the current alternative technologies on the market today, the present treatment has proven to cause more rapid and decisive healing. In addition, the patients have enjoyed permanent, persistent improvements in the circulation of the affected limb.
.
A treatment regimen of forty-five minutes a day has been effective in a very high percentage of patients treated resulting in remarkable changes in both neural conductivity and wound healing rates. Most importantly, patients report a high level of comfort with treatment.
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Even with a relatively high phase charge, the comfort level to the patient remains acceptable over extended periods of time, during which the muscle groups are contracting. During moderate muscle contraction, blood rates can increase from 10 to 25 times the patient's resting blood flow. While only 20 to 25 percent of muscle capillaries are open during rest, nearly all of the dormant capillaries open up during moderate muscle contraction. Because of the decreased oxygen concentration in the tissue fluid (because of increased oxygen demands from the contracting muscles), vasodilation of the vessels is triggered by release of adenosine and other vasodilator substances, to the extent that any vasodilation is possible. In addition, lymph will not flow freely from resting muscle. However, the contracting muscles will squeeze or pump the lymph vessels and capillaries resulting in increased flow rates. With this increased fluid perfusion due to passive repetitive contractions (static work, an unopposed, involuntary muscle contraction) there is little tactic acid build up and most importantly there is more oxygenated blood, due to the pumping action of the muscles exerted on the arterial side.
.
Prior to the procedure and machine herein described, there are well- defined protocols for treatment of wounds. Many of these same protocols are followed in conjunction with the present methods. A similar example obtains with chemotherapy in the treatment of malignant tumors. In chemotherapy, besides attacking the target tumor, there are numerous undesirable side effects. The side effects would be less if the chemotherapy dosage were reduced. The effect on the tumor would also be reduced, unless there were some means to make the tumor more susceptible to the chemotherapy. It is found that the present methods have precisely that effect by increasing fluid perfusion in the tumor and the vicinity thereof.
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(technical data omitted)
.
An underlying characteristic of the above conditions and diseases is impaired circulation in-the capillary beds as well as nerve damage. Without blood flow to the tissues, oxygen and nutrients cannot get into the tissues and the waste products of metabolism cannot get out. This puts a severe stress on the tissues causing them to go into a survival mode. The cells use what limited resources they have to stay alive and higher functions, including healing and repair, as well as tissue mediated immunity, become essentially shut down. In most patients with severe disease, measured tissue oxygen levels have been found to be less than 15% of normal. Diabetics with impaired basement membrane function, Reynauds phenomena, Claudication states and other similar conditions all may have similar features due to this underlying characteristic.
.
Essentially, every tissue in the body has intrinsic electrical properties.
.
Because of this, it has been found that they respond to electrical stimulation.
.
There have been many machines designed over the years to use electricity to affect the body in various ways to enhance the healing process. There are many variables in the use of electricity, including polarity, voltage, amperage,frequency and waveform. Although there are a variety of alternate technologies available today, the electronic parameters of known machines have limited applications.
.
Hyperbaric oxygen therapy has been shown to be effective in healing ischemic ulcers. 100% oxygen at 2 atmospheres will give a partial pressure of oxygen 10 times normal. This greatly increases the rate of diffusion through the open face of the ulcer. Skin, however, is not as permeable to oxygen diffusion and oxygen delivery depends upon intact circulation as well. Hyperbaric oxygen therapy is a passive process and does not alter the underlying disease in the microcirculation.
.
There are several procedures in practice using moist heat with occlusion dressings, infrared lamps, membranes with electrical currents and warm water whirlpool treatments. These have all shown some merit and have been effective in varying degrees. They all work by stimulating the arterioles in the capillary beds to dilate in response to infrared energy. These also are passive procedures, however, and do not alter the underlying disease in the microcirculation.
.
Machines using high frequency interferential electrical currents are also effective. They stimulate the nerves in the skin and cause dilation of the capillary beds through the reflex pathways. However, this form of electrical current tends to be more superficial in the tissues and, therefore, less decisive and rapid in its healing effects.
.
Another procedure being used today consists of a garment placed around the diseased limb. Intermittent compression is then administered via compressed air from the attached machine. This again has proven to be effective to promote circulation and healing. by pumping the blood through the capillary beds. Pressure gradients are increased in the capillary beds but there is not necessarily the dilation of the arterioles as the other methods promote.
.
This procedure does not remodel the microcirculation either.
.
It is, therefore, an object of this invention to provide an electrical tissue treating procedure and machine which increases circulation in capillary beds.
.
Another object of this invention is to provide an electrical tissue treating procedure and machine which significantly remodels microcirculation so as to provide more permanent therapeutic improvement. A further object of this invention is to provide an electrical tissue treating procedure and machine which not only dilates arterioles but also, increases pressure gradients across the capillary beds to improve flow and oxygen levels and promote angiogenesis.
.
Yet another object of this invention is to provide an electrical tissue treating procedure and machine which provides deep layered muscle contractions and perfuses tissues with blood so as to afford more decisive and rapid healing than known methods and machines. It is also an object of this invention to provide an electrical tissue treating procedure and machine which facilitates more rapid and decisive healing of vascular deficiency ailments than known procedures and machines.
.
SUMMARY OF THE INVENTION : In accordance with the invention, a procedure and machine are provided to promote healing by causing muscle fasciculation and contraction relaxation cycles that effectively pump blood through the microcirculation, draining the venous beds and raising the tissue oxygen levels. This, in turn, supplies the oxygen and substrates necessary to greatly accelerate the healing process.
.
Pressure gradients are actually increased across the capillary beds with perfusion of blood into the designated area of the patient, in contrast to merely dilating the capillary beds. Therefore, the treatment has a potent effect on the microcirculation, which results in dramatic responses to treatment.
.
Transcutaneous oxygen monitors have demonstrated marked increases in tissue oxygen levels within minutes of initiating treatment. Tissue oxygen levels with successive treatments continue to improve.
.
A high phase charged system is electronically pulsed and adjusted to induce deep-layered muscle contractions, causing greatly increased flow rates of both blood and lymphatics, patency of vessels permitting, and forcing blood into the microcirculation of the treated tissue.
.
The machine electrical waveform stimulates angiogenesis, that is, budding of new capillaries and generation of denser capillary networks in the tissues. This lays the groundwork for new tissue growth and repair in the healing process. The machine electrical waveform also raises the metabolic rate in the treated tissues, which, it is theorized, helps the intimal lining of the arteries to metabolize the excess unused nutrients clogging them. Whatever the actual cause, the effect is improved blood flow that has been shown to be permanent, particularly in patients with neuropathy.
.
The procedure and machine have been tested on diabetics with severe ischemic ulcers in feet that were destined for amputation. This condition is usually associated with underlying osteomeyelitis, which does not respond well to standard therapy including systemic antibiotics and wound care. The present treatment greatly improves the management of this condition because theenhanced blood flow brings enhanced levels of antibiotics and healing to the affected area. In almost every case, the feet have been salvaged.
.
In addition, the machine's electrical waveform directly stimulates the activity of fibroblasts in the healing process. In the healing of ischemic ulcers the fibroblasts act first to build the framework upon which further cell types including skin and capillaries grow. The electrical current is a deep penetrating current that affects all tissues from the skin to the bone. Technically, the machine generates an [electrical] field between the emitter pads, in contrast to the electrical waveform of some machines that stay rather superficial in the tissues affecting primarily the top several millimeters. The system stimulates activity in bone cells as well, which accelerates fracture healing.
.
Finally, the procedure and machine have achieved excellent test case success in reversing neuropathy in the feet and legs of diabetics being treated.
.
In follow up on this condition thus far, improvement has persisted for extended periods of time. There is no other known technology or treatment modality that has reversed diabetic neuropathy. The reason for this unique therapeutic benefit is not known. It may be due to improvement in the circulation that nourishs the nerves or due to an unknown direct action on the nerves themselves.
.
The procedure and machine have shown remarkable efficacy in dealing with the above difficult disease states. In comparison with the current alternative technologies on the market today, the present treatment has proven to cause more rapid and decisive healing. In addition, the patients have enjoyed permanent, persistent improvements in the circulation of the affected limb.
.
A treatment regimen of forty-five minutes a day has been effective in a very high percentage of patients treated resulting in remarkable changes in both neural conductivity and wound healing rates. Most importantly, patients report a high level of comfort with treatment.
.
Even with a relatively high phase charge, the comfort level to the patient remains acceptable over extended periods of time, during which the muscle groups are contracting. During moderate muscle contraction, blood rates can increase from 10 to 25 times the patient's resting blood flow. While only 20 to 25 percent of muscle capillaries are open during rest, nearly all of the dormant capillaries open up during moderate muscle contraction. Because of the decreased oxygen concentration in the tissue fluid (because of increased oxygen demands from the contracting muscles), vasodilation of the vessels is triggered by release of adenosine and other vasodilator substances, to the extent that any vasodilation is possible. In addition, lymph will not flow freely from resting muscle. However, the contracting muscles will squeeze or pump the lymph vessels and capillaries resulting in increased flow rates. With this increased fluid perfusion due to passive repetitive contractions (static work, an unopposed, involuntary muscle contraction) there is little tactic acid build up and most importantly there is more oxygenated blood, due to the pumping action of the muscles exerted on the arterial side.
.
As an example, take the lower leg as an area to be treated for healing a diabetic ulcer on the foot. The emitter pads are applied to the anterior and posterior muscle compartments of the lower leg. This will achieve muscle contractions in the anterior compartment, consisting of the anterior tibial and the extensor group and of the posterior compartment consisting of the gastrosoleus, flexors and peroneals. As these muscles pump oxygenated blood to the tibial and peroneal arteries and their smaller branches, the velocity and flow increases. The viscosity of the blood decreases and the red blood cells reach a desirable state of deformability. These erythrocytes are able, with increased velocity and ellipsoidal shape, to reach tissue they were blocking or unable to migrate through previously. In addition to the enhanced perfusion of compromised tissues, the increase in blood flow and passive exercise in often debilitated muscles, reduces the effects of muscle disuse atrophy. This sets in motion a therapeutic cycle of increased mobility by the patient. When walking and weight bearing is desirable, the patient is literally contributing to their own improvement in circulatory status by increased walking and well-being..
Prior to the procedure and machine herein described, there are well- defined protocols for treatment of wounds. Many of these same protocols are followed in conjunction with the present methods. A similar example obtains with chemotherapy in the treatment of malignant tumors. In chemotherapy, besides attacking the target tumor, there are numerous undesirable side effects. The side effects would be less if the chemotherapy dosage were reduced. The effect on the tumor would also be reduced, unless there were some means to make the tumor more susceptible to the chemotherapy. It is found that the present methods have precisely that effect by increasing fluid perfusion in the tumor and the vicinity thereof.
.
(technical data omitted)
... Thus, it is apparent that there has been provided, in accordance with the invention, a procedure and machine that fully satisfy the objects, aims and advantages set forth above. While the invention has been described in conjunction with a specific embodiment thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art and in light of the foregoing description. Accordingly, it is intended to embrace all such alternatives, modifications and variations as fall within the spirit of the appended claims
